Trial of Pemetrexed and Bevacizumab for Recurrent Ovarian Primary Peritoneal Carcinoma
This study has been completed.
Sponsor:
Washington University School of Medicine
Collaborator:
Columbia University
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00868192
First received: March 18, 2009
Last updated: December 20, 2012
Last verified: December 2012
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Purpose
The purpose of this study is to determine if the combination of bevacizumab and pemetrexed have an effect on recurrent ovarian and primary peritoneal carcinoma by looking at progression and survival at 6 months.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Carcinoma Primary Peritoneal Carcinoma |
Drug: pemetrexed and bevacizumab combination therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Trial of Pemetrexed and Bevacizumab for Recurrent Ovarian Primary |
Resource links provided by NLM:
Further study details as provided by Washington University School of Medicine:
Primary Outcome Measures:
- To determine the anti-tumor activity of the combination of bevacizumab and pemetrexed as measured by progression-free survival in patients with recurrent epithelial ovarian or primary peritoneal carcinoma [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To estimate the distribution of progression-free survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- To estimate the distribution of overall survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- To determine the toxicity associated with bevacizumab and pemetrexed [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- To determine the frequency of clinical response, as assessed by RECIST criteria, to the combination regimen of bevacizumab and pemetrexed [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- To correlate patterns of gene expression as assessed by Illumina cDNA mediated annealing, selection, extension and ligation (DASL) microarray from paraffin-embedded tumor specimens with response to pemetrexed and bevacizumab [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
- To determine the association between levels of thymidylate synthase, dihydrofolate reductase, and glycinamide ribonucleotide formyl transferase and ovarian response to pemetrexed and bevacizumab [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
| Enrollment: | 39 |
| Study Start Date: | June 2008 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Pemetrexed and bevacizumab |
Drug: pemetrexed and bevacizumab combination therapy
Pemetrexed 500 mg/m2 IV and bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle
|
Detailed Description:
Patients will be treated with pemetrexed 500 mg/m2 IV and Bevacizumab 15 mg/kg IV every 3 weeks.The patient is treated indefinitely until side effects are deemed severe by the investigator or until progression. Disease progression is measured every 6 weeks using RECIST criteria.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Recurrent epithelial ovarian or primary peritoneal carcinoma
- Measurable disease
- At lease 1 target lesion to assess response by RECIST
- GOG performance status 0 or 1
- Recovery from effects of recent surgery, radiotherapy or chemotherapy, must discontinue hormonal therapy
- Must have had 1 prior platinum based chemotherapeutic regimen for management of primary disease
- Must have had 1 prior regimen containing a taxane compound
Exclusion Criteria:
- Prior therapy with pemetrexed or bevacizumab
- Serious, non-healing wound, ulcer or bone fracture
- Clinically significant cardiovascular disease
- Active bleeding or pathogenic conditions that carry high risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major - vessels
- Ascites or other third space fluid which cannot be controlled by drainage
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to day 1 or anticipation of need for major surgical procedure during course of study
- History or evidence upon physical exam of CNS disease, including primary brain tumor, brain mets, seizure not controlled with standard medical therapy, history of CVA/stroke/TIA, or subarachnoid hemorrhage within 6 mos. of day 1
- Proteinuria
- History of abdominal fistula, GI perforation or intra-abdominal abscess within 6 mo.
- Partial or complete small or large bowel obstruction within 3 mo.
- Life expectancy less than 12 weeks
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00868192
Locations
| United States, Missouri | |
| Washington University | |
| St. Louis, Missouri, United States, 63110 | |
| United States, New York | |
| Columbia University | |
| New York City, New York, United States, 10027 | |
Sponsors and Collaborators
Washington University School of Medicine
Columbia University
Investigators
| Principal Investigator: | David G Mutch, MD | Washington University School of Medicine |
| Principal Investigator: | Jason D Wright, MD | Columbia University |
More Information
Additional Information:
Publications:
| Responsible Party: | Washington University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00868192 History of Changes |
| Other Study ID Numbers: | 08-0508 / 201102272 |
| Study First Received: | March 18, 2009 |
| Last Updated: | December 20, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Carcinoma Ovarian Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Pemetrexed |
Bevacizumab Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Antimetabolites, Antineoplastic Antimetabolites Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013